Imaging Techniques to Characterize Cake Appearance of Freeze-Dried Products

Journal of Pharmaceutical Sciences
Christina HaeuserAndrea Allmendinger

Abstract

Pharmaceutically elegant lyophilisates are highly desirable implying a stable and robust freeze-drying process. To ensure homogenous and intact cake appearance after process scale-up and transfer, characterization of lyophilisates during formulation and cycle development is required. The present study investigates different imaging techniques to characterize lyophilisates on different levels. Cake appearance of freeze-dried bovine serum albumin formulations with different dextran/sucrose ratios was studied by visual inspection, three-dimensional laser scanning, polydimethylsiloxane embedding, scanning electron microscopy, and microcomputed tomography (μ-CT). The set of techniques allowed a holistic evaluation of external cake appearance and internal structure providing complementary information at macroscopic and microscopic scale. In comparison to state of the art technologies like visual inspection or scanning electron microscopy, three-dimensional laser scanning and μ-CT provided quantitative information allowing comparison of visual cake appearance. In particular μ-CT enables a global, qualitative, and quantitative characterization of external and internal cake structure with a single measurement detecting heterogeneities o...Continue Reading

Citations

Jul 8, 2020·Materials·Wannes GoethalsMatthieu N Boone
Apr 2, 2021·The Journal of Pharmacy and Pharmacology·Tim WenzelHenning Gieseler
May 31, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Marieke E Klijn, Jürgen Hubbuch
Oct 4, 2020·International Journal of Pharmaceutics·Maria Badal TejedorAnna Millqvist-Fureby

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